SMART Stepped Care Management for Low Back Pain in the Military Health System

Not Applicable

Active, not recruiting

• Conditions: Low Back Pain; Chronic Pain; Military Personnel; Veterans
• Interventions: Behavioral: MORE Mindfulness; Behavioral: Move 2 Health (M2H); Behavioral: Physical Therapy

• Registration Number: NCT04172038
• Lead Sponsor: Brooke Army Medical Center

Brief Summary

This study will be sequential, randomization trial where patients with chronic low back pain are initially randomized to receive 1 of 2 treatments (physical therapy OR Move 2 Health). This will be Phase I of the study intervention. Patients who do not respond to treatment after 6 weeks will undergo a subsequent sequential randomization. This will be Phase II of the study intervention. Patients in Phase II will be randomized to receive 1 of 2 treatments (addition of physical therapy or Move 2 Health, whichever one they did not receive OR the MORE Mindfulness intervention). Patients will be followed for 1 year after enrollment.

Detailed Description

Improving non-pharmacologic management of chronic pain is a priority for the Military Health System (MHS) within the Department of Defense (DoD) and the most common chronic pain condition in the MHS and civilian healthcare is low back pain (LBP). Key questions exist however about the relative effectiveness of various strategies at different Steps, how to sequence treatments and individualize care based on specific patient characteristics and the resource implications. This study will recruit active duty military members or members of Reserves or National Guard on active duty, family members of active duty personnel, or Tricare beneficiaries seeing a primary care provider for chronic LBP in an MHS facility, ages 18-65. All participants will first receive 6 weeks of Phase I care with either physical therapy (PT) or Move to Health (M2H) interventions. After Phase I the investigators will assess response to initial treatment strategy. Phase I responders will be receive up to 2 additional sessions of treatment to facilitate a transition to self-management. Phase I non-responders will be randomly assigned to a more intensive Phase II treatment of either mindfulness or a combined PT+M2H intervention for 8 weeks. Randomization at each phase will be stratified by site, gender, and active duty status (adding Phase I treatment assignment at Phase II). Follow-up assessments for all participants will occur at 18 weeks (conclusion of Phase II), 6 months and 12 months after enrollment. Outcomes include patient-reported measures and health care costs.

Study Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2019-12-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

1. Active duty military member (Army, Navy, Air Force, Marines) or member of Reserves or National Guard on active duty, a family member of active duty personnel, or Tricare beneficiary receiving care in a participating Military Treatment Facility.

2. Age 18 - 65 years at the time of enrollment.

3. Receiving Step 1 chronic LBP care based on VA Stepped Care Pain Management model defined as:

   a. Seen by a health care provider for chief complaint of LBP with or without symptoms into the buttocks or legs within past the 30 days.

   • Chief complaint of LBP which may be self-reported or identified by primary International Classification of Disease (ICD), 10th edition codes of LBP (M54.5, M54.9, S33.012), lumbar degenerative change (M51.36, M51.37, M48.06, M47.817), lumbar disc herniation/radiculitis (M54.16, M54.17, M51.26, M51.27, M54.3).

4. Meets NIH Task Force145 definition of chronic LBP based on two questions:

   How long has LBP has been an ongoing problem for you? and How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.

5. Anticipates ability to attend treatment sessions over a 16 week period following enrollment with no planned absence of 2 weeks or more for training, vacation or any purpose.

Exclusion Criteria

1. Signs of serious or systemic pathology as a cause of LBP including spine fracture, neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
2. Knowingly pregnant
3. Has received interventions for LBP that involves providers other than primary care in the past 6 months. This includes physical therapy or behavioral pain management or counseling as well as specialist physician consultations, chiropractic, etc.
4. Has received any interventional pain procedures (e.g., spinal injections), inter-disciplinary pain management, integrated chronic pain and substance use treatment programs, etc. in the past 6 months
5. Has received any lumbar spine surgery in the past year.
6. Retiring from active duty within 12 months, pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury.
7. At elevated acute risk for suicide (i.e., risk is below the level requiring either consultation or urgent action based on Veterans Affairs-Department of Defense Clinical Practice Guideline for Assessment and Management of Patients at Risk for Suicide)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase II: MORE Mindfulness	MORE Mindfulness	Sequential Randomization: Participants randomized to receive mindfulness as a Phase II intervention will discontinue their Phase I treatment. The Mindfulness-Oriented Recovery Enhancement (MORE) treatment was designed specifically to address symptoms and underlying mechanisms of chronic pain in the military context and is led over 8 individual sessions.
Phase I: Move to Health (M2H)	Move 2 Health (M2H)	Initial Randomization: M2H is a key component of Army Medicine's "System for Health", along with the Performance Triad. It is a person-centered, holistic, and experience-centric approach to promoting healthy behaviors (nutrition, physical activity, sleep, instrinsic factors, extrinsic factors). Precise dosage (i.e, number of M2H sessions) will be at the discretion of the health coaches. Sessions may be delivered in-person or utilize technology including text messaging, telephone, e-mail, video chat, app-based self-management etc.
Phase II: Combine PT & M2H	Physical Therapy	Sequential Randomization: Participants randomized to receive a combination of PT and M2H as a Phase II intervention will continue their Phase I treatment (either M2H or PT). The participant will begin the treatment component that was not part of their Phase I intervention.
Phase I: Physical Therapy (PT)	Physical Therapy	Initial Randomization: The initial PT treatment session will occur within 7 days of enrollment in the study. Precise dosage (i.e, number of PT sessions) will be at the discretion of the physical therapist directing the participant's care, up to a maximum of 2-3 sessions per week over the 6-week Phase I treatment period.
Phase II: Combine PT & M2H	Move 2 Health (M2H)	Sequential Randomization: Participants randomized to receive a combination of PT and M2H as a Phase II intervention will continue their Phase I treatment (either M2H or PT). The participant will begin the treatment component that was not part of their Phase I intervention.

Primary Outcome Measures

Name	Time	Method
PROMIS-Pain Interference Computer Adapted Test (PI-CAT)	1 year	Computer-adapted assessment using a 44-item bank measuring the self-reported consequences of pain on relevant aspects of life including impact on social, emotional, cognitive, physical and recreational activities. All Patient-Reported Outcomes Measurement Information System (PROMIS®) scores are reported on a T-score metric with a score of 50 points aligning with the general population mean and a standard deviation of 10. Higher scores indicate greater pain interference.

Secondary Outcome Measures

Name	Time	Method
PROMIS Physical Function Computer Adapted Test (PF-CAT)	1 year	Computer-adapted assessment using a 121-item bank measuring current, self-reported capability related to physical activities. All PROMIS scores are reported on a T-score metric with a score of 50 points aligning with the general population mean and a standard deviation of 10. Higher scores indicate greater physical function.

Trial Locations

Locations (4)

Desmond Doss Health Clinic; 🇺🇸 Schofield Barracks, Hawaii, United States

Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States

Wilford Hall Ambulatory Surgical Center; 🇺🇸 San Antonio, Texas, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States